NCT03544112: ED-CONNECT

Emergency Department Connection to Care With Buprenorphine for Opioid Use Disorder

Completed Last updated 30 August 2019

What this trial tests

trial testing Employ a multifaceted approach to facilitate clinical protocol implementation in Opioid-use Disorder in 390 participants. Completed in 29 May 2019.

Timeline

11 June 2018

Primary endpoint
29 May 2019

29 May 2019

Quick facts

Lead sponsor	NYU Langone Health
Status	Completed
Study type	OBSERVATIONAL
Enrollment	390
Start date	11 June 2018
Primary completion	29 May 2019
Estimated completion	29 May 2019
Sites	4 locations across United States

Drugs / interventions tested

• Employ a multifaceted approach to facilitate clinical protocol implementation
• Initiate BUP (SL-BUP or XR-BUP) in the ED — full drug profile →

Conditions studied

• Opioid-use Disorder — all drugs for Opioid-use Disorder →

Sponsor

NYU Langone Health — full company profile →

Who can join

18 and older, any sex, with Opioid-use Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to learn what resources are needed to improve outcomes for patients with opioid use disorder. The study will look at how patients engage in treatment and the decisions that patients and providers make regarding treatment, specifically buprenorphine treatment, for opioid use disorder.

The aims of this study are:

1. To evaluate using mixed methods the feasibility and acceptability of OUD screening, ED-initiated BUP, and referral.
2. Over the course of the study and as XR-BUP is added to hospital formularies, to estimate the percentage and confidence intervals of patients assessed, treated, and engaged in treatment at Day 30. This will be a three-site study employing a multi-faceted approach to facilitate clinical protocol implementation and to assess feasibility, acceptability, and impact. Investigators will develop, introduce and update site-specific ED clinical protocols and implementation plans for OUD screening, ED-initiated BUP, and referral for treatment. A participatory action research approach will be utilized along with mixed methods incorporating data derived from:

* Medical record and administrative data abstraction,
* Research assessments involving patients who are eligible for and willing to receive ED-initiated BUP (including both those who do, and do not, receive BUP); these assessments will document the index ED visit and the 30th day after the index ED visit,
* Qualitative interviews, focus groups, and quantitative assessments involving providers and staff, patients, and other stakeholders.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Implementing Programs to Initiate Buprenorphine for Opioid Use Disorder Treatment in High-Need, Low-Resource Emergency Departments: A Nonrandomized Controlled Trial.
   McCormack RP, Rotrosen J, Gauthier P, D'Onofrio G, et al · · 2023 · cited 8× · PMID 37140493 · DOI 10.1016/j.annemergmed.2023.02.013
2. Implementation facilitation to introduce and support emergency department-initiated buprenorphine for opioid use disorder in high need, low resource settings: protocol for multi-site implementation-feasibility study.
   McCormack RP, Rotrosen J, Gauthier P, D'Onofrio G, et al · · 2021 · cited 8× · PMID 33750454 · DOI 10.1186/s13722-021-00224-y